Expandable Titanium PLIF/TLIF System

Intervertebral Fusion Device With Bone Graft, Lumbar

Spectrum Spine, LLC

The following data is part of a premarket notification filed by Spectrum Spine, Llc with the FDA for Expandable Titanium Plif/tlif System.

Pre-market Notification Details

Device IDK201024
510k NumberK201024
Device Name:Expandable Titanium PLIF/TLIF System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Spectrum Spine, LLC 4020 Stovall Terrace NE Atlanta,  GA  30342
ContactJames Robinson
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-20
Decision Date2021-04-29

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